Research Assistant, sIRB

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

The Department of Neurology is seeking a Research Assistant, sIRB to support the BIOS Clinical Trials Coordinating Center (CTCC), which manages multi-center, 30+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. BIOS CTCC, is also an NIH (National Institutes of Health) funded JHU Trials Innovation Center (TIC), incorporates the TIC, as part of the NIH Trial Innovation Network (TIN) initiative to address roadblocks in clinical trials and accelerating the translation of novel interventions into life-saving therapies. The sIRB Research Assistant will provide support for research projects managed by the JHM IRB serving as the central IRB of record for TIC and non-TIC projects. The Research Program Assistant is responsible for communications, data collection, entry, analysis, and reporting and document management functions. They will also provide support to the Division faculty, administrator, and research personnel.

The Research Assistant, sIRB will report to the IRB navigators and program managers for large multisite clinical trials in managing central IRB documents and agreements in online systems, creating reports, and distributing documents;

Specific Duties & Responsibilities

• Track agreement execution status, uploads documents to online repositories, records activity dates, and reports status summaries.
• Develop and maintain records of research activities, and prepares regular and ad hoc reports, as required.
  
• Assist in the maintenance of project databases.
  
• Assist in the development of tables and figures for reports and presentations.
  
• Assist in the coordination and participates in research team meetings which will include: scheduling meetings, creating agendas and meeting minute transcription.
  
• Assist in preparing IRB protocols and related documents.
  
• Communicate with study sites to request documents and answer inquiries.
  
• Perform miscellaneous job-related duties as assigned.
  
• Identify and report site issues to managers.
  

Special Knowledge, Skills & Abilities

• Must have strong organizational skills, attention to detail, be able to work independently and an ability to work with a team of researcher managers.
  
• Strong IT skills and ability to learn new software program.
  

• Ability to follow multiple, detailed directions of various protocols.
  
• Must have excellent time management skills.

Minimum Qualifications

• Bachelor’s Degree in related field with some related experience.
• Additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula
  

Preferred Qualifications

• IRB knowledge preferred.
• Knowledge of medical terminology highly desired.
• Basic knowledge of FDA, ICH and other regulatory guidelines related to IRB oversight.
• Experience with JHM IRB policy guidelines and systems.

Classified Title: Research Assistant
Job Posting Title (Working Title): Research Assistant, sIRB
Role/Level/Range: ACRO40/E/03/CD
Starting Salary Range: $17.00 - $30.00 HRLY ($48,880 budgeted; commensurate with experience)
Employee group: Full Time
Schedule: Monday - Friday 8:30 am - 5:00 pm
Exempt Status: Non-Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Neuro BIOS
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm